Sodium Glucose Co-Transporter 2 (SGLT2) Inhibitors to Treat Heart Failure with Preserved Ejection Fraction in Patients with Atrial Fibrillation - The SHAPE-AF Trial

SGLT-2 Inhibitors to Treat Heart Failure with Preserved Ejection Fraction in Adults Males and Females with Symptomatic Atrial Fibrillation Requiring AF Ablation. - The SHAPE-AF Trial

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12626000399392

Enrollment

140

Registered

2026-03-31

Start date

2026-04-01

Completion date

2027-07-31

Last updated

2026-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Subclinical heart failure with preserved ejection fraction is common amongst patients with atrial fibrillation and is associated with poorer exercise capacity and worse symptoms. SGLT2-inhibitors are an established treatment for patients with overt heart failure. Their efficacy in patients with AF and subclinical heart failure with preserved ejection fraction has not been established. We hypothesise that the use of SGLT2-inhibitors post-ablation will reduce AF recurrence rates in patients with AF and haemodynamically confirmed HFpEF. This study will randomise patients with AF and subclinical HFpEF to either dapagliflozin 10mg daily or placebo and will assess improvement in peak oxygen consumption on cardiopulmonary exercise testing as the primary outcome.

Interventions

SGLT2-inhibitor (Dapagliflozin 10mg daily). This is an oral tablet to be taken once daily for a duration of 12 months.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

Male

Age

18 Years to 85 Years

Healthy volunteers

Inclusion criteria

1) 18 years old or older, 2) symptomatic paroxysmal or persistent AF, 3) undergoing AF ablation procedure, 4) mean left atrial pressure (mLAP) greater than or equal to 15mmHg at rest or after infusion of 500mls normal saline directly into the left atrium during the AF ablation procedure

Exclusion criteria

1) permanent AF, 2) asymptomatic AF, 3) contraindication to SGLT2-inhibitor treatment, 4) receiving SGLT2-inhibitor treatment at time of enrolment, 5) previous diagnosis of heart failure, 6) left ventricular ejection fraction <50%, 7) moderate to severe valvopathy, 8) ischaemic or non-ischaemic cardiomyopathy, 9) musculoskeletal diseases or injuries limiting exercise capacity, 10) chronic pulmonary disease requiring home oxygen, 11) oral steroid therapy or hospitalisation for exacerbation within 12 months. • women who are pregnant, nursing, or who plan to become pregnant • presence of any other disease than heart failure with a life expectancy of <1 year in the principal investigator’s opinion

Outcome results